Chronic Low-back Pain (cLBP)NCT06999772
Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain
A study testing Active rTMS, Psychologically-informed physiotherapy (PiP) and Usual physiotherapy in people with Chronic Low-back Pain (cLBP), run by Laval University at 2 sites in Canada.
Trial summary
Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Active rTMS, Psychologically-informed physiotherapy (PiP) and Usual physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 65 years old
- Military Veterans with non-specific chronic low back pain (> 3 months, > 50% of the days in the last 6 months)
- High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool
- Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)
Who cannot join
- Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, fracture)
- Diagnosis of drug or alcohol abuse
- Change of drug dosage in the last month for the treatment of pain or mental health
- Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
Québec, Quebec, G1M 2S8
Hugo Massé-Alarie, 418-529-9141 ext. 6930, hugo.masse-alarie@fmed.ulaval.ca
Jean Tittley, 418-529-9141 ext. 2478, jean.tittley@cirris.ulaval.ca
- Not yet recruiting
Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, Quebec, G1M 2S8
About this study
Official title: Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans
Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.
Read the detailed description
The study will compare the effects of (1) combining rTMS with PiP, (2) PiP alone (+sham rTMS), and (3) usual physiotherapy (UP) on physical functioning in Veterans suffering from CLBP and comorbid psychological factors associated with back pain. Participants will undergo an 8-week intervention program. Validated questionnaires will be used to measure outcomes at baseline, 2-, 8-, and 26-week follow-ups. The main objective is to determine if the combination of PiP and rTMS is superior to PiP and UP alone to improve physical functioning in Veterans suffering from CLBP and comorbid psychological factors.
The secondary objectives are to compare the effectiveness of these interventions on secondary outcomes, that are, pain intensity, quality of life, movement pain-related fear, pain catastrophizing, self-efficacy, depression symptoms, medication use and post-traumatic stress disorder symptoms.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Active rTMS, Sham rTMS, Psychologically-informed physiotherapy (PiP), Usual physiotherapy
- Keywords
- Non-invasive brain stimulation, comorbid psychological risk factors, chronic pain, repetitive transcranial magnetic stimulation, physiotherapy, pyschologically-informed, veterans
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Also called Repetitive Transcranial Magnetic Stimulation
A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). Stimulation parameters will be obtained by measuring the motor threshold of the first right interosseous muscle, then the rTMS intensity will be set at 110% of this motor threshold. High frequency (HF) rTMS consisting of 60 trains of 5 s at 10 Hz with 15 s intertrain intervals, for a total of 3000 pulses per session, will be used. The coil will be positioned over the left dorsolateral PFC using the BeamF3 methods.
Sham rTMSDevice
Also called Sham Repetitive Transcranial Magnetic Stimulation
A sham coil will be used (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS and will be located over the same area (dorso-lateral prefrontal cortex).
Psychologically-informed physiotherapy (PiP)Other
Participants will receive 6 intervention sessions (45 min) over 6 weeks by a physiotherapist. The objective of this intervention is to identify biopsychosocial factors that may impede recovery and to address these factors within the physiotherapist's scope of practice. Physiotherapists will use strategies such as the establishment of common goals and therapeutic alliance, the use of behavior change model, motivational interview, education on pain neurophysiology, gradual exposure to movement and stress management strategies (e.g. breathing techniques). Participants allocated to PiP groups will have access to a website offering support information related to understanding their pain (e.g. pain neuroscience education), myths and false beliefs related to back pain, understanding the impact of psychological factors on their pain, self-management strategies, and healthy lifestyle habits. This site will be freely available to participants during the course of the study.
Usual physiotherapyOther
Participants will receive 6 intervention sessions (45 min) over 8 weeks by a physiotherapist. This is a pragmatic group that aims to represent real-word clinical practice i.e. interventions commonly used in physiotherapy to manage CLBP. All interventions that a physiotherapist can deliver in the province of Quebec will be allowed (e.g. manual therapy, exercises). No training will be provided to better reflect usual clinical practice in physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS + PiP | Experimental | For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation).
In the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions. Receives: Device: Active rTMS; Other: Psychologically-informed physiotherapy (PiP) |
| Sham rTMS + PiP | Sham comparator | For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions. Receives: Device: Sham rTMS; Other: Psychologically-informed physiotherapy (PiP) |
| Usual physiotherapy | Active comparator | Participants will attend 6 sessions within 8 weeks (1session /week for 4 weeks, 1 session every 2 weeks between weeks 5-8). Each physiotherapy will last 30-45 min. Receives: Other: Usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning (ODI)
The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability). The total score ranges from 0 (no disability) to 100% (maximal disability).
Measured: Baseline, weeks 2, 8 and 26.
Secondary outcomes (10)
Pain intensity (NPRS)
The Numerical Pain Rating Scale (NPRS) is an 11-point scale used to measure the mean intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline, weeks 2, 8 and 26.
Quality of life (EQ-5D-5L)
The EQ-5D-5L is a self-administrated questionnaire that contains 5 questions, each rated on a 5-point scale and mesuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions define 5^5 = 3125 possible health states, which can be converted into a Canadian weighted index score. This index score ranges from -0.148 (lowest value assigned to a health state) to 0.949 (highest value assigned to a health state).
Measured: Baseline, weeks 2, 8 and 26.
Depression symptoms (PHQ)
The Patient Health Questionnaire is a self-administrated questionnaire of 9 questions used to diagnose depression and grade severity of symptoms. The scale ranges from 0 to 27; a higher score means more depressive symptoms.
Measured: Baseline, weeks 2, 8 and 26.
Pain catastrophizing (PCS)
The Pain Catastrophizing Scale (PCS) is a self-administrated questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point scale ranging from 0 (not at all, low level of catastrophizing thoughts) to 5 (all the time, high level of catastrophizing thoughts).
Measured: Baseline, weeks 2, 8 and 26.
Fear of movement (TSK-13)
The Tampa Scale of Kinesiophobia is a self-administrated questionnaire used to assess fear of movement using 13 questions on a 4-point scale ranging from 1 (strongly disagree, low level of kinesiophobia) to 4 (strongly agree, high level of kinesiophobia).
Measured: Baseline, weeks 2, 8 and 26
Self-efficacy (PSEQ-10)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire mesuring the confidence people with ongoing pain have in performing activities while in pain, on a 10-point scale from 0 (not at all confident, low self-efficacy) to 10 (completely confident, high self-efficacy).
Measured: Baseline, weeks 2, 8 and 26.
Post-traumatic stress disorder (PCL-5)
The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20-item self-completed questionnaire that assesses the 20 DSM-5 symptoms of post-traumatic stress disorder on a 5-point scale ranging from 0 (not a all, no symptoms of PTSD) to 4 (extremely, severe symptoms of PTSD).
Measured: Baseline, weeks 2, 8 and 26.
Medication use
The Medication Quantification Scale Version 4 quantifies the risk weights of the use of 36 drug sub-classes used in pain management. Each drug sub-class has a detriment weight from 0 (low risk weight) to 10(high risk weight). The total score represents the summation of each drug class used by the participant.
Measured: Baseline, weeks 2, 8 and 26.
Global rating of change (GRC)
The Global rating of change (GRC) is a 11-point scale ranging from -5 (a great deal worst) to 5 (a great deal better) to measure the perceived change of health status after the intervention.
Measured: Weeks 2, 8 and 26
Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State (PASS) measures if the participants consider their current functional and symptoms states as satisfactory or not. A visual analogue scale ranging from 0 (completely dissatisfied) to 100 (completely satsified) is used.
Measured: Baseline, weeks 2, 8 and 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start11 Jun 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind, parallel-group, monocentric, randomised controlled trial (RCT).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Chronic Pain Centre of Excellence for Canadian Veterans, Foundation for Physical Medicine and Rehabilitation
- Responsible party
- Principal investigator, Hugo Massé-Alarie, Laval University
- Investigators
- Hugo Massé-Alarie, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999772
- Sponsor's protocol ID
- 2025-3215 : DLPFC - PiP
- Status last verified
- Jan 2026
- First submitted
- 22 May 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) that underlie the results reported in the published article will be made available. The study protocol will also be published.
Publications
Dupuis F, Tousignant-Laflamme Y, Marier Deschenes P, Fournier P, Nduwimana I, Ballot O, Loisel L, Pinard AM, Lacombe L, Langevin P, Gaumond A, Roy JS, Masse-Alarie H. Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 26;15:e78952. doi: 10.2196/78952.
PubMed 41587077
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans
- ClinicalTrials.gov ID
- NCT06999772
- Acronym / sponsor ID
- 2025-3215 : DLPFC - PiP
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Non-invasive brain stimulation, comorbid psychological risk factors, chronic pain, repetitive transcranial magnetic stimulation, physiotherapy, pyschologically-informed, veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Chronic Pain Centre of Excellence for Canadian Veterans, Foundation for Physical Medicine and Rehabilitation
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.
Detailed description
The study will compare the effects of (1) combining rTMS with PiP, (2) PiP alone (+sham rTMS), and (3) usual physiotherapy (UP) on physical functioning in Veterans suffering from CLBP and comorbid psychological factors associated with back pain. Participants will undergo an 8-week intervention program. Validated questionnaires will be used to measure outcomes at baseline, 2-, 8-, and 26-week follow-ups. The main objective is to determine if the combination of PiP and rTMS is superior to PiP and UP alone to improve physical functioning in Veterans suffering from CLBP and comorbid psychological factors.
The secondary objectives are to compare the effectiveness of these interventions on secondary outcomes, that are, pain intensity, quality of life, movement pain-related fear, pain catastrophizing, self-efficacy, depression symptoms, medication use and post-traumatic stress disorder symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- This is a single-blind, parallel-group, monocentric, randomised controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Active rTMS + PiP | Experimental | Device: Active rTMS, Other: Psychologically-informed physiotherapy (PiP)For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions. |
| Sham rTMS + PiP | Sham comparator | Device: Sham rTMS, Other: Psychologically-informed physiotherapy (PiP)For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions. |
| Usual physiotherapy | Active comparator | Other: Usual physiotherapyParticipants will attend 6 sessions within 8 weeks (1session /week for 4 weeks, 1 session every 2 weeks between weeks 5-8). Each physiotherapy will last 30-45 min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between 18 and 65 years old
- Military Veterans with non-specific chronic low back pain (> 3 months, > 50% of the days in the last 6 months)
- High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool
- Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)
Key exclusion criteria (4 listed)
- Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, fracture)
- Diagnosis of drug or alcohol abuse
- Change of drug dosage in the last month for the treatment of pain or mental health
- Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMSAlso: Repetitive Transcranial Magnetic StimulationA figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). Stimulation parameters will be obtained by measuring the motor threshold of the first right interosseous muscle, then the rTMS intensity will be set at 110% of this motor threshold. High frequency (HF) rTMS consisting of 60 trains of 5 s at 10 Hz with 15 s intertrain intervals, for a total of 3000 pulses per session, will be used. The coil will be positioned over the left dorsolateral PFC using the BeamF3 methods. | Device | Active rTMS + PiP |
| Sham rTMSAlso: Sham Repetitive Transcranial Magnetic StimulationA sham coil will be used (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS and will be located over the same area (dorso-lateral prefrontal cortex). | Device | Sham rTMS + PiP |
| Psychologically-informed physiotherapy (PiP)Participants will receive 6 intervention sessions (45 min) over 6 weeks by a physiotherapist. The objective of this intervention is to identify biopsychosocial factors that may impede recovery and to address these factors within the physiotherapist's scope of practice. Physiotherapists will use strategies such as the establishment of common goals and therapeutic alliance, the use of behavior change model, motivational interview, education on pain neurophysiology, gradual exposure to movement and stress management strategies (e.g. breathing techniques). Participants allocated to PiP groups will have access to a website offering support information related to understanding their pain (e.g. pain neuroscience education), myths and false beliefs related to back pain, understanding the impact of psychological factors on their pain, self-management strategies, and healthy lifestyle habits. This site will be freely available to participants during the course of the study. | Other | Active rTMS + PiP, Sham rTMS + PiP |
| Usual physiotherapyParticipants will receive 6 intervention sessions (45 min) over 8 weeks by a physiotherapist. This is a pragmatic group that aims to represent real-word clinical practice i.e. interventions commonly used in physiotherapy to manage CLBP. All interventions that a physiotherapist can deliver in the province of Quebec will be allowed (e.g. manual therapy, exercises). No training will be provided to better reflect usual clinical practice in physiotherapy. | Other | Usual physiotherapy |
Primary outcome
Physical functioning (ODI)
Time frame: Baseline, weeks 2, 8 and 26.
The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability). The total score ranges from 0 (no disability) to 100% (maximal disability).
10 secondary outcomes
Pain intensity (NPRS)
Time frame: Baseline, weeks 2, 8 and 26.
Quality of life (EQ-5D-5L)
Time frame: Baseline, weeks 2, 8 and 26.
Depression symptoms (PHQ)
Time frame: Baseline, weeks 2, 8 and 26.
Pain catastrophizing (PCS)
Time frame: Baseline, weeks 2, 8 and 26.
Fear of movement (TSK-13)
Time frame: Baseline, weeks 2, 8 and 26
Self-efficacy (PSEQ-10)
Time frame: Baseline, weeks 2, 8 and 26.
Post-traumatic stress disorder (PCL-5)
Time frame: Baseline, weeks 2, 8 and 26.
Medication use
Time frame: Baseline, weeks 2, 8 and 26.
Global rating of change (GRC)
Time frame: Weeks 2, 8 and 26
Patient Acceptable Symptom State (PASS)
Time frame: Baseline, weeks 2, 8 and 26.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 41587077Dupuis F, Tousignant-Laflamme Y, Marier Deschenes P, Fournier P, Nduwimana I, Ballot O, Loisel L, Pinard AM, Lacombe L, Langevin P, Gaumond A, Roy JS, Masse-Alarie H. Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 26;15:e78952. doi: 10.2196/78952.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) that underlie the results reported in the published article will be made available. The study protocol will also be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hugo Massé-Alarie, PhD principal investigator
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS, Psychologically-informed physiotherapy (PiP) and Usual physiotherapy in people with Chronic Low-back Pain (cLBP), run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Massé-Alarie, PhD ((418) 529 9141 ext. 46642, hugo.masse-alarie@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning (ODI) (time frame: Baseline, weeks 2, 8 and 26.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06999772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.